Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Handling Comparison Between Two Contact Lens Types

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310126
Recruitment Status : Completed
First Posted : December 5, 2014
Results First Posted : March 31, 2016
Last Update Posted : June 19, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
Subjects will evaluate each study lens in a random order. The lenses will be worn in both eyes for a short period.

Condition or disease Intervention/treatment Phase
Presbyopia Device: etafilcon A (multi-focal) Device: etafilcon A (sphere) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : December 1, 2014
Actual Study Completion Date : December 1, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Active Comparator: etafilcon A(sphere)/etafilcon A(multi-focal)
Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (sphere) contact lens first and then the etafilcon A (multi-focal) contact lens second.
Device: etafilcon A (multi-focal)
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Other Name: Investigational Multifocal Contact

Device: etafilcon A (sphere)
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Other Name: 1-DAY ACUVUE® MOIST®

Active Comparator: etafilcon A(multi-focal)/etafilcon A(sphere)
Subjects were randomized to one of two lens wear sequences. subjects randomized to this sequence received etafilcon A (multi-focal) contact lens first and then the etafilcon A (sphere) contact lens second.
Device: etafilcon A (multi-focal)
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Other Name: Investigational Multifocal Contact

Device: etafilcon A (sphere)
Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
Other Name: 1-DAY ACUVUE® MOIST®




Primary Outcome Measures :
  1. Overall Lens Handling Using the Contact Lens User Experience(CLUE) TM Questionnaire. [ Time Frame: 15 minutes post Contact Lens Insertion ]
    CLUE Overall Lens Handling is assessed using the Contact Lens User Experience (CLUE)TM questionnaire. CLUE is a validated patient-reported outcomes questionnaire to assess patient experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. 97% of the scores fall within 0 and 120 (mean +/-3XSD).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. The subject must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
  2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. The subject must be between 40 and 70 years of age.
  4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of +0.25 to +4.00 or plano to -6.00 in each eye.
  5. The subject's refractive cylinder must be less than or equal to -0.75 D in each eye.
  6. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
  7. The subject best corrected visual acuity of 20/20 -3 or better in each eye.
  8. Subject must own a wearable pair of spectacles.
  9. The subject must be an adaptable soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 8 hours per day, for 1 month or more of duration)
  10. The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not responded positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".

Exclusion Criteria:

  1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
  3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
  4. Any ocular abnormality that may interfere with contact lens wear.
  5. Use of any ocular medication, with the exception of rewetting drops.
  6. Any previous intraocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
  7. Any grade 3 or greater slit lamp finding (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
  8. Any ocular infection or inflammation.
  9. History of herpetic keratitis.
  10. Any corneal distortion or irregular cornea.
  11. History of binocular vision abnormality or strabismus.
  12. Any infectious disease (e.g. hepatitis, tuberculosis) or contagious immunosuppressive disease (e.g. HIV).
  13. Current history of diabetes.
  14. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310126


Locations
Layout table for location information
United States, Florida
Baymeadows Vision Center
Jacksonville, Florida, United States, 32256
Eye Elements Eyecare
Jacksonville, Florida, United States, 32256
Vistakon Research Clinic
Jacksonville, Florida, United States, 32256
Golden Family Eyecare
Sarasota, Florida, United States, 34232
Eye Associates of Winter Park
Winter Park, Florida, United States, 32792
United States, Ohio
Central Ohio Eyecare
Columbus, Ohio, United States, 43202
United States, Tennessee
Optometry Group LLC
Memphis, Tennessee, United States, 38111
Nashville Vision Associates
Nashville, Tennessee, United States, 37205
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

Layout table for additonal information
Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT02310126     History of Changes
Other Study ID Numbers: CR-5570
First Posted: December 5, 2014    Key Record Dates
Results First Posted: March 31, 2016
Last Update Posted: June 19, 2018
Last Verified: June 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Presbyopia
Refractive Errors
Eye Diseases